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Mandibular Furcation III Regeneration (FURC-III-REGEN) (FURC-III-REGEN)

Primary Purpose

Furcation Defects, Periodontal Diseases

Status
Recruiting
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Furcation Defects

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must be ≥ 20 years
  • Subject must have periodontal disease as determined by the World Workshop 2017 criteria
  • Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
  • Competent to give consent

Exclusion Criteria:

The following must not be present at the time of enrolment;

  • Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
  • Present or past use of bisphosphonate treatment
  • Pregnant or nursing subjects
  • Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
  • Previous surgical therapy of included furcation defects
  • Inability to comprehend and respond to the quality of life questionnaire
  • Dental restorations or prosthesis involving the furcation area
  • Root fractures or suspected infractions
  • Caries lesions in the furcation area
  • No systemic antibiotic treatment within 3 months prior to intervention

Sites / Locations

  • Institute of Clinical Dentistry, Faculty of Dentistry, University of OsloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regenerative therapy w/BCP and collagen membrane

Regenerative therapy w/BCP and enamel matrix proteins

Arm Description

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.

Outcomes

Primary Outcome Measures

Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Change of furcation grade level
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe

Secondary Outcome Measures

Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Changes in defect morphology assessed by CBCT
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Changes in pocket probing depth
Changes in pocket probing depth will be measured with a probe
Changes in pocket probing depth
Changes in pocket probing depth will be measured with a probe
Changes in PPD
Changes in pocket probing depth will be measured with a probe
Changes in PPD
Changes in pocket probing depth will be measured with a probe
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Radiographic changes
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Pain following surgery
Pain sensation one week posteoperatively will be recorded on a visual analog scale from 0-10. 0 means no pain sensation, whereas 10 means highest pain imagineable.
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Caries assessment
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)

Full Information

First Posted
August 6, 2019
Last Updated
May 19, 2022
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT04059458
Brief Title
Mandibular Furcation III Regeneration (FURC-III-REGEN)
Acronym
FURC-III-REGEN
Official Title
Biphasic Calcium Phosphate and a Collagen Membrane or Biphasic Calcium Phosphate and Enamel Matrix Proteins, in the Regenerative Treatment of Furcation Grade III Defects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 15, 2027 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Teeth with furcation grade III defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regenerative therapy w/BCP and collagen membrane
Arm Type
Experimental
Arm Description
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.
Arm Title
Regenerative therapy w/BCP and enamel matrix proteins
Arm Type
Active Comparator
Arm Description
In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.
Intervention Type
Device
Intervention Name(s)
Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)
Intervention Description
Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
Intervention Type
Drug
Intervention Name(s)
Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)
Intervention Description
Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
Primary Outcome Measure Information:
Title
Change of furcation grade level
Description
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Time Frame
12 months after treatment
Title
Change of furcation grade level
Description
Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe
Time Frame
24 months after treatment
Secondary Outcome Measure Information:
Title
Changes in patient-reported quality of life (QoL)
Description
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Time Frame
Preoperatively compared to 24 months after treatment
Title
Changes in patient-reported quality of life (QoL)
Description
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1).
Time Frame
Preoperatively compared to 12 months after treatment
Title
Changes in defect morphology assessed by CBCT
Description
Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months
Time Frame
24 months after treatment
Title
Changes in pocket probing depth
Description
Changes in pocket probing depth will be measured with a probe
Time Frame
12 months after treatment
Title
Changes in pocket probing depth
Description
Changes in pocket probing depth will be measured with a probe
Time Frame
24 months after treatment
Title
Changes in PPD
Description
Changes in pocket probing depth will be measured with a probe
Time Frame
12 months after treatment
Title
Changes in PPD
Description
Changes in pocket probing depth will be measured with a probe
Time Frame
24 months after treatment
Title
Radiographic changes
Description
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time Frame
12 months after treatment
Title
Radiographic changes
Description
Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs
Time Frame
24 months after treatment
Title
Pain following surgery
Description
Pain sensation one week posteoperatively will be recorded on a visual analog scale from 0-10. 0 means no pain sensation, whereas 10 means highest pain imagineable.
Time Frame
Up to 1 week postoperatively
Title
Caries assessment
Description
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time Frame
24 months
Title
Caries assessment
Description
Caries in furcation defect assessed with an explorer will be recorded as (Y/N)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be ≥ 20 years Subject must have periodontal disease as determined by the World Workshop 2017 criteria Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD >4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level Competent to give consent Exclusion Criteria: The following must not be present at the time of enrolment; Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment Present or past use of bisphosphonate treatment Pregnant or nursing subjects Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification Previous surgical therapy of included furcation defects Inability to comprehend and respond to the quality of life questionnaire Dental restorations or prosthesis involving the furcation area Root fractures or suspected infractions Caries lesions in the furcation area No systemic antibiotic treatment within 3 months prior to intervention
Facility Information:
Facility Name
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
City
Oslo
ZIP/Postal Code
0455
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Verket, PhD
Phone
+47 93667661
Email
anderver@odont.uio.no
First Name & Middle Initial & Last Name & Degree
Odd Koldsland, PhD
Phone
+47 93098618
Email
oddcko@odont.uio.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Mandibular Furcation III Regeneration (FURC-III-REGEN)

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